Drugs

Drug, Device Recalls Up in 2nd Quarter

The Stericycle Recall Index for the second quarter of 2016 shows that drug recalls are up from the first quarter, but still well below historical trends dating back to 2004. Recalls rose 35% to their highest level since the third quarter of 2014, the report says. And recalled units increased even more substantially, by 169%.

Some 66% of recalled units were Class 2, the firm says, resuming an historical trend after a lower-than-average first quarter, when Class 2 accounted for 33% of recalled units. The average event size was nearly 110,000 units, almost double the average from the first quarter, but still below the historical trend of 150,000 units. Some 14 companies experienced more than one recall, the highest level in a quarter since the second quarter of 2015. Overall, 79% of the pharmaceutical recalls were nationwide.

For medical devices, the number of recalls increased 38%, putting the second quarter of 2016 in a tie for highest quarter since the third quarter of 2014. Stericycle says that recalled medical device units were three times higher in the second quarter, but still 30% lower than the quarterly average in 2015. Some 99% of recalled units were considered Class 2, continuing a trend that began in the first quarter of 2015.

The top three causes based on medical device recalls were software, mislabeling, and quality issues, making up a combined 51% of all recalls. Based on units, the top causes were quality issues (39.7%), out-of-specification (26%), sterility issues (22.2%), mislabeling (4.3%), and manufacturing defects (3.7%). Some 60% of medical device recalls were nationwide, and 49% were international, which was the lowest level of international recalls since the fourth quarter of 2013.

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome